In vitro evaluation of a novel fluoride-coated clear aligner with antibacterial and enamel remineralization abilities

Jiarong Yan, Lingyun Cao, Ting Luo, Danchen Qin, Fang Hua, Hong He

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OBJECTIVE: To investigate the antibacterial and enamel remineralization performances as well as physicochemical properties and biocompatibility of a fluoride-coated clear aligner plastic (FCAP).

MATERIALS AND METHODS: FCAP and normal clear aligner plastic (CAP) was bought from the manufacturer (Angelalign Technology Inc, China). The FCAP was observed under scanning electron microscopy. Its element composition, resistance to separation, contact angle, and protein adhesion performance were characterized. Colony-forming unit (CFU) count and 3-(4,5)-dimethylthiazol(-z-y1)-3,5-diphenyltetrazolium bromide (MTT) assay were used to evaluate the antibacterial ability of Streptococcus mutans. Fluoride release-recharge patterns were obtained. Apatite formation was evaluated after immersing FCAP in artificial saliva. Enamel remineralization capability was evaluated in the demineralization model (immersing samples in demineralization solution for 36 h) and pH cycling model (immersing samples in demineralization solution and remineralization solution in turns for 14 days). Cell Counting Kit-8 (CCK-8) and live/dead cell staining kits were used for cytotoxicity assay.

RESULTS: The FCAP showed uniformly distributed fluoride and did not compromise protein adhesion performance. CFU count (5.47 ± 0.55 for CAP, 3.63 ± 0.38 for FCAP) and MTT assay (0.41 ± 0.025 for CAP, 0.28 ± 0.038) indicated that the FCAP had stronger antibacterial activity compared with normal CAP (P < 0.05 for both evaluations). The FCAP could release fluoride continuously for 14 days and could be recharged after immersing in NaF solution. The FCAP could induce the formation of hydroxyapatite in artificial saliva and could reduce the microhardness decrease, color change, and mineral loss of enamels in both two models (P < 0.05 for all evaluations). CCK-8 and live/dead cell staining analyses showed that the coating did not compromise the biocompatibility of the clear aligner (P > 0.05 for CCK-8 evaluation).

CONCLUSIONS: The FCAP had antibacterial, fluoride recharge, and enamel remineralization abilities while it did not compromise physicochemical properties and biocompatibility.

CLINICAL RELEVANCE: The FCAP has the potential to prevent enamel demineralization during clear aligner treatment.

Original languageEnglish
Pages (from-to)6027-6042
Number of pages16
JournalClinical Oral Investigations
Issue number10
Publication statusPublished - 24 Aug 2023


  • Humans
  • Fluorides/pharmacology
  • Tooth Demineralization/prevention & control
  • Saliva, Artificial
  • Tooth Remineralization
  • Hydrogen-Ion Concentration
  • Dental Enamel
  • Anti-Bacterial Agents/pharmacology
  • Orthodontic Appliances, Removable
  • Dental Caries/prevention & control
  • Sodium Fluoride/pharmacology
  • Cariostatic Agents/therapeutic use


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